7.1.3 Generalized impairment or mental incompetence which would relinquish 
the patient unable to understand his/her participation in the study. 
7.1.4 If, in the Investigator’s medical judgment, further participation would be 
injurious to the subject’s health or well-being. 
7.1.5 Administrative reasons, such as subject non-compliance or a major 
protocol violation. 
7.1.6 Pregnancy 
An explanation will be recorded for any patient that is taken off treatment and the 
a ppropriate Case Report Form completed . 
7.2 Criteria for Study Discontinuation 
Patients should understand that once they have received one vaccination, they will 
be asked to be followed long-term. They can stop study treatment at any time 
(see section 7.1), however they will still be considered on study until the study 
has been terminated. 
The study can be discontinued only with the understanding of the investigators, 
sponsor, RAC and the FDA. 
8.0 ADVERSE EXPERIENCES 
A ppendix III is Adverse Experience Reporting 
Depending on the extent of the adverse experience, adverse events should be reported by 
the investigator to their local Institutional Review Board (IRB), Institutional BioSafety 
Committee (IBC) and to Genetic Therapy, Inc. (collaborating company) as specified in 
Appendix III. 
Adverse reactions or deaths requiring immediate reporting should be made by telephone 
to (301) 590 2626 (available 24 hours a day, recorder after working hours). 
The sponsor, Genetic Therapy, Inc. will take the responsibility of informing and 
preparing reports for the Recombinant Advisory Committee (RAC) through the NTH 
Office of Recombinant DNA Activities (ORDA) and to the FDA. 
HHS Guidelines for Research Involving Recombinant DNA Molecules : It is the 
responsibility of the institution and those associated with it to adhere to the intent of the 
Guidelines as well as to their specifics. 
[4281 
Recombinant DNA Research, Volume 18 
